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@article{921643,
author = {Rossi, J. F. and Négrier, S. and James, N. D. and Kocák, Ivo and Hawkins, R. and Davis, H. and Prabhakar, U. and Qin, X. and Mulders, P. and Berns, B.},
article_number = {8},
doi = {http://dx.doi.org/10.1038/sj.bjc.6605872},
keywords = {metastatic renal cell cancer; interleukin-6; siltuximab; C-reactive protein},
language = {eng},
issn = {0007-0920},
journal = {British journal of cancer},
title = {A phase I/II study of siltuximab (CNTO 328), an anti-interleukin-6 monoclonal antibody, in metastatic renal cell cancer},
volume = {103},
year = {2010}
}
TY - JOUR
ID - 921643
AU - Rossi, J. F. - Négrier, S. - James, N. D. - Kocák, Ivo - Hawkins, R. - Davis, H. - Prabhakar, U. - Qin, X. - Mulders, P. - Berns, B.
PY - 2010
TI - A phase I/II study of siltuximab (CNTO 328), an anti-interleukin-6 monoclonal antibody, in metastatic renal cell cancer
JF - British journal of cancer
VL - 103
IS - 8
SP - 1154-1162
EP - 1154-1162
SN - 00070920
KW - metastatic renal cell cancer
KW - interleukin-6
KW - siltuximab
KW - C-reactive protein
N2 - Serum interleukin (IL)-6 levels correlate with disease outcomes in renal cell carcinoma (RCC) patients. Siltuximab, a chimeric, murine-human mAb against IL-6, was evaluated in a three-part phase I/II study in patients with progressive metastatic RCC. METHODS: In part 1, 11 patients received 1, 3, 6, or 12 mg kg(-1) at weeks 1, 4 and q2w x 2 thereafter; in part 2, 37 patients randomly received 3 or 6 mg kg(-1) q3w x 4; in part 3, 20 low-risk patients received 6 mg kg(-1) q2w x 6. Modified WHO response criteria were assessed at weeks 7, 11, the 6-week follow-up, and when clinically indicated. RESULTS: Siltuximab was well tolerated overall, with no maximum tolerated dose or immune response observed. In all, 5 out of 11, 17 out of 37, and 9 out of 20 patients in parts 1, 2, and 3, respectively, received extended treatment beyond 4-6 initial infusions. In part 2, stable disease (SD) (>= 11weeks) or better was achieved by 11 out of 17 (65%) 3mg kg(-1) treated patients (one partial response (PR) similar to 8 months, 10 SD) and 10 out of 20 (50%) 6 mg kg(-1) treated patients (10 SD). In part 3, documented complete or PR was not observed, but 13 out of 20 (65%) patients achieved SD. CONCLUSION: Siltuximab stabilised disease in >50% of progressive metastatic RCC patients. One PR was observed. Given the favourable safety profile of siltuximab and poor correlation of tumour shrinkage with clinical benefit demonstrated for other non-cytotoxic therapies, further evaluation of dose-escalation strategies and/or combination therapy may be considered for patients with RCC.
ER -
ROSSI, J. F., S. NÉGRIER, N. D. JAMES, Ivo KOCÁK, R. HAWKINS, H. DAVIS, U. PRABHAKAR, X. QIN, P. MULDERS a B. BERNS. A phase I/II study of siltuximab (CNTO 328), an anti-interleukin-6 monoclonal antibody, in metastatic renal cell cancer. \textit{British journal of cancer}. 2010, roč.~103, č.~8, s.~1154-1162. ISSN~0007-0920. Dostupné z: https://dx.doi.org/10.1038/sj.bjc.6605872.
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